CE Marking on Multiple-Components Medical Products

H

hugbe

#1
Hi Experts,
I would like to get a better idea on how to CE mark a medical product consisting of multiple components. As an example: a laser focusing hand piece consisting of a hand piece body, different focusing lenses, different sleeves matching in length with the focal length of the lenses.
Conformity assessment is performed with all the components. A final product is configured by the user. When he is ordering a focusing hand piece with a focal length of - let me say 20 mm and 40 mm, he will receive a ready assembled focusing hand piece and in addition an extra lense and a compatible sleeve. In the definition of the MDD the lense and sleeves are accessories and should be classified independent of the final product. However - what is the classification of a lense or a sleeve? And - in addition to it - what is about the marking? Shall all components carry a CE mark or just the Main Product?
Next Example:
A laparoscopic instrument which is dismountable for cleaning reasons. You may find an outer shaft, an inner shaft, a luer-lock connector and a closing cap for a luer connector. In addition you may have different insert tubings and a distal actuator. The user may use it with or without an inner shaft, may use different actuators and so on. How to mark the instrument and what is about the classification of the components?
Simple Question:
What is about a closing cap for a luer-lock connector? It is an accessory in my understanding and so would have to be classified separately? This seems very strange to me - and what is about the CE mark? Does it have to have a CE mark?
Thank you all for your qualified comments and proposals.
Bernhard
 
#2
Hello experts,

I'm also having the same question with our product & accessories.

Experts help us to have the better understanding on this topic.

We have received the CE marking with Accessories which is tested with the main system. If we want to sell that accessories separately, whether we have to get different EC certificate to place CE mark for that accessory? in that case how we will classify the device?


Thanking you for the clarification.

With Regards,
Krishna Priya T
 
#4
Hello,
There are far too many questions here, so lets get down to the basics:

In the MDD, Article 1.1 says:
"This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices."

Article 1.2 defines the meaning of accessory:
"‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;"

Let me point out two things:
1. Accessories are treated like medical devices. That means that they must bear the CE mark on them. If it's a class I accessory just the CE mark; if its a class II or above then the CE mark with the identification number of the notified body.

2. Your declaration of conformity is an important document for this purpose. It identifies the classification of your device and accessories. In most cases that I have seen the manufacturers have two declarations of conformity - one for the device with higher classification, and one for the accessories with lower classification (usually class I).

Chew on this and see if it makes sense to you.

Cheers,
Shimon
 
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Ronen E

Problem Solver
Staff member
Super Moderator
#5
Hi,

Before plunging into questions about how to handle Accessories, one needs to make sure that they're actually dealing with Accessories (in the official sense).

Q1: Who makes the so-called "accessory"? Their intentions are paramount in the determination of whether or not that item is officially an Accessory to a Medical Device.

Q2: Is the so-called accessory intended by its Manufacturer for a specific device (or a finite list of specific devices - not a type of devices)? If not, it's not an Accessory.

Q3: Is the so-called accessory intended by its Manufacturer to ENABLE the Device/Devices from Q2 to achive its / their intended use (as its / their own Manufacturer/s has/have called out)? If not, it's not an Accessory. Please note that "enable" means that it/they wouldn't be able to achive the intended use(s) without that item!

Is it actually an Accessory, or a Comoponent (or a Part)?

The official Accessory definition can be read neatly on some components / parts, too. Unfortunately, existing regulations provide little clarification or guidance to distinguish the two categories. Based on my experience and general knowledge of regulations and guidance, I've developed my own rule to tell Accessories from Components (or Parts):

A Component is an object that was already offered for sale as an integral part* of another medical device (excluding a medical device which is "a System or Procedure Pack" in the regulatory sense), and is also being offered for sale on its own, for use with the same device model; whilst an item that may be offered for sale for use with/in a medical device model, without previously being integrally included in any sale configuration of the same device model, may be** an Accessory.

*) "Integral part" doesn't necessarily mean that the object is assembled in/to the medical device; it only means that they are offered for sale as one unit, under the same PN, labelling, packaging etc.

**) To actually be an Accessory in the regulatory sense it'd have to satisfy additional conditions, as stated in the regulatory definition of an Accessory to a medical device - I didn't include these conditions in the above definition for readability reasons.

Challenges are welcome.
 
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#6
Hello Sirs,

Thank you.

Kindly help me on the below Queries.

1. In the Accessories, CE mark can be placed in accordance with the certificate which is provided for the main system along with the accessories?

2. Can we sell the Accessories separately with the CE mark - with the reference to the main system certifications?
 
#7
Hi Krishna,
I will try to answer your questions even though I have no knowledge about your product configuration. Take it with limited warranty :)

1. In the Accessories, CE mark can be placed in accordance with the certificate which is provided for the main system along with the accessories?
Generally speaking - yes. Accessories are really not much different than devices, expect for their supporting role. The MDD treats accessories like devices.


2. Can we sell the Accessories separately with the CE mark - with the reference to the main system certifications?
Yes, providing that the accessories are included in the system Technical File and covered in the Declaration of Conformity.


BR,
Shimon
 

Ronen E

Problem Solver
Staff member
Super Moderator
#9
In general, whatever item that is listed in an EC certificate (be it a medical device or an accessory to a medical device) can, and probably should, be CE marked and can be sold on its own.

Accessories to Medical Devices (in the official sense) that are not explicitly included in any EC certificate's scope - be it their "parent" device's certificate or their own - can't and shouldn't be CE marked or sold on their own.

The above applies to Accessories that are classified higher than class I non-sterile & non-measuring. Plain class I (NSNM) accessories require either being explicitly included in a parent-device EC certificate's scope, or being notified to (registered with) a member state's Competent Authority in their own right (like class I devices).

Spare parts (=Components) of a CE-marked device don't need to (and probably shouldn't) be CE marked, but they can still be sold on their own, as such - spare parts. Their packaging and accompanying paperwork should, however, clarify that these are components of/for duly CE-marked Medical Devices; in the presence of such clarification I would consider CE-marking their shipping/sales packages, as necessary. I wouldn't CE-mark the component itself, though.
 
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